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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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PACTR |
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Last refreshed on:
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29 April 2013 |
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Main ID: |
PACTR201206000391313 |
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Date of registration:
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14/06/2012 |
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Primary sponsor: |
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Public title:
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The pharmacokinetics of lopinavir/ritonavir, nevirapine and efavirenz when given with isoniazid in South African HIV-infected individuals
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Scientific title:
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The pharmacokinetics of lopinavir/ritonavir, nevirapine and efavirenz when given with isoniazid in South African HIV-infected individuals |
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Date of first enrolment:
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2012-06-21 |
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Target sample size:
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70 |
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Recruitment status: |
Open to recruitment: actively recruiting participa |
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URL:
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HTTP://www.pactr.org/ATMWeb/appmanager/atm/atmregistry?da=true&tno=PACTR201206000391313 |
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Study type:
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interventional |
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Study design:
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Crossover: all participants receive all interventions in different sequence during study,
Non-randomised,
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Countries of recruitment
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South Africa
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Contacts
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Name:
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Eric
Decloedt |
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Address:
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7925
Obeservatory
South Africa |
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Telephone:
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021 406 6353 |
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Email:
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eric.decloedt@uct.ac.za |
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Affiliation:
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Division of Clinical Pharmacology |
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Name:
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Eric
Decloedt |
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Address:
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7925
Observatory
South Africa |
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Telephone:
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021 406 6353 |
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Email:
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eric.decloedt@uct.ac.za |
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Affiliation:
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Division of Clinical Pharmacology |
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Key inclusion & exclusion criteria
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Inclusion criteria: Stable on ART: efavirenz, nevirapine or lopinavir/ritonavir
Exclusion criteria: Hepatitis
Pregnant
Using CYP450 inducers/inhibitors
Excessive alchol use
Intolerant to isoniazid
Age minimum:
18 Year
Age maximum:
100 Year
Gender:
Both
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Health Condition(s) or Problem(s) studied
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HIV/AIDS
Tuberculosis
null
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Primary Outcome(s)
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Pharmacokinetics of lopinavir
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Secondary Outcome(s)
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Safety
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Secondary ID(s)
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HREC no 047/2011
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MCC no N2/19/8/2 (0838)
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Source(s) of Monetary Support
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South African Medical Research Council
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